{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "product_ndc": "84546-0001",
      "generic_name": "BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B",
      "labeler_name": "ELIXIR HEALTHCARE USA, LLC.",
      "brand_name": "ElixirTripleGuard Triple Antibiotic",
      "brand_name_suffix": "Triple Antibiotic",
      "active_ingredients": [
        {
          "name": "BACITRACIN ZINC",
          "strength": "400 [USP'U]/g"
        },
        {
          "name": "NEOMYCIN SULFATE",
          "strength": "3.5 mg/g"
        },
        {
          "name": "POLYMYXIN B SULFATE",
          "strength": "5000 U/g"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "84546-0001-1",
          "description": "28.3 g in 1 TUBE (84546-0001-1)",
          "marketing_start_date": "20251224",
          "sample": false
        },
        {
          "package_ndc": "84546-0001-2",
          "description": "144 PACKET in 1 BOX (84546-0001-2)  / .9 g in 1 PACKET",
          "marketing_start_date": "20251224",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "ELIXIR HEALTHCARE USA, LLC."
        ],
        "rxcui": [
          "204602"
        ],
        "spl_set_id": [
          "43edfb80-4d50-9362-e063-6394a90a2199"
        ],
        "is_original_packager": [
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        "unii": [
          "89Y4M234ES",
          "057Y626693",
          "19371312D4"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "OINTMENT",
      "spl_id": "45ded1dd-d9c1-555d-e063-6294a90a059e",
      "product_type": "HUMAN OTC DRUG",
      "route": [
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      ],
      "marketing_start_date": "20251224",
      "product_id": "84546-0001_45ded1dd-d9c1-555d-e063-6294a90a059e",
      "application_number": "M004",
      "brand_name_base": "ElixirTripleGuard",
      "pharm_class": [
        "Aminoglycoside Antibacterial [EPC]",
        "Aminoglycosides [CS]",
        "Decreased Cell Wall Synthesis & Repair [PE]",
        "Polymyxin-class Antibacterial [EPC]",
        "Polymyxins [CS]"
      ]
    }
  ]
}